Launch of Recombinant Human Coagulation Factor VIII for Injection and Nuoyi®

July 31, 2021, developed by Novo Nordisk production of injection of recombinant human coagulation factor Ⅷ promise Yi ® officially listed in China, for the treatment of adults and children with hemophilia
.

On the same day, the "Eisen Guarding Hemophilia A Patient Assistance Project" was launched simultaneously, aiming to provide financial assistance to hemophilia patients who have received Nuoyi® treatment and meet the relevant conditions, and support patients to receive standardized and sustainable treatments.
Return to society
.

The aid project was initiated and operated by the China Primary Health Care Foundation and the Beijing National Institute of Health Medicine, and received public welfare support from Novo Nordisk

Hemophilia is an X-chromosome-linked recessive hereditary bleeding disorder, which can be divided into hemophilia A and hemophilia B1.
Once the disease occurs, it will be accompanied for life
.

"After the injury, the blood flow will not stop, the "glass man" who cannot be touched".

The "Guidelines for the Treatment of Hemophilia in China (2020 Edition)" pointed out that the alternative treatment of hemophilia A should be genetically recombinant FⅧ preparations or virus-inactivated blood-derived FⅧ preparations1
.

Professor Yang Renchi, director of the Thrombosis and Hemostasis Center of the Hospital of Hematology (Institute of Hematology) of the Chinese Academy of Medical Sciences, and leader of the National Hemophilia Collaboration Group, introduced: “Factor replacement therapy is currently the most important method for the treatment of hemophilia.

In the process of treatment, the risk of inhibitors is one of the difficulties in the treatment of patients with hemophilia
.

In recent years, there has been an increasing trend of hemophilia patients with inhibitors2, which has increased the difficulty of treatment, and at the same time increased the disability and mortality of patients3

Professor Ren-tank, said: "Snow Easy ® in the world has accumulated a wealth of efficacy and safety data for the prevention and treatment of bleeding
in the Chinese market is easy to promise ®, provides a new treatment option for adult patients with hemophilia and children.

       Nuoyi® is the second hemophilia drug developed by Novo Nordisk.
The first hemophilia drug, Nuoqi® (recombinant human coagulation factor VIIa for injection), was launched globally in 1996 and used 5.
4 million doses8
.

Novo Nordisk's journey to change hemophilia began in 1985-to support Dr.

       In recent years, with the continuous improvement of medical insurance policies, China's hemophilia treatment and protection cause has made great progress
.

Mr.

       Zhou Xiaping, Senior Vice President and President of Greater China of Novo Nordisk, said: “As a global leader in biopharmaceuticals, we are very pleased to bring Nuoyi® into China and provide Chinese patients with hemophilia A more effective and safer.
Treatment options
.

Faced with the unmet needs of patients in the field of hemophilia, Novo Nordisk will continue to innovate and continue to provide new treatment options to meet the ever-changing treatment needs of patients with hemophilia

       Recently, the first domestic prescription of Nuoyi® officially landed in Shanghai, and it is expected that it will bring more clinical benefits to patients with hemophilia A in China
.

       Reference source:

       1.
Thrombosis and Hemostasis Group of Hematology Branch of Chinese Medical Association, Chinese Hemophilia Collaborative Group.
Chinese Journal of Hematology, 2017, 38(5):364-370.

       2.
Thrombosis and Hemostasis Group of Hematology Branch of Chinese Medical Association, Chinese Hemophilia Collaborative Group.
Chinese Journal of Hematology, 2018, 39(10): 793-799.

       3.
Wang Shixuan, Yang Renchi.
Research progress of hemophilia A inhibitors[J].
Chinese Journal of Hematology,2017,38 (5): 444-448.

       4.
Instructions for Recombinant Human Coagulation Factor VIII for Injection (December 29, 2020 version)

       Thim L, et al.
Haemophilia 2010;16:349–59.

       Christiansen MLS, et al.
Haemophilia 2010;16:878–87.

       Ellgaard TW, et al.
Protein Expression and Purification, 2016, 129.

       Lentz SR et al.
Haemophilia 2018; 24:e391–e394.

       Wu R, et al.
Ther Clin Risk Manag.
2020;16:567-578.

       CarmenEscuriola-Ettingshausen, et al.
2021 EAHAD,Abstract ABS210

       5.
Wu R, et al.
TherClin Risk Manag.
2020;16:567-578.

       6.
At the time of the research, this study was the first study in China to prospectively evaluate the effectiveness of rFVIII for preventive treatment in all age groups and patients in China.
Its design complies with the European Medicines Agency's FVIII product clinical research and development guidelines
.

       7.
8 cases of surgery have a record of curative effect

       8.
The overall exposure to rFVIIa in all approved indications from January 1, 1996 to December 31, 2016
.
The total exposure is based on the number of standard doses-defined as 90μg/kg and the average individual body weight is 40kg.
Reference: Neufeld EJ et al.
Haemophilia 2018;24:e275–e277.

       About China Primary Health Care Foundation

       The China Primary Health Care Foundation (hereinafter referred to as the Primary Insurance) is sponsored by the Central Committee of the China Peasants and Workers Democratic Party and is in charge of the National Health and Family Planning Commission.
It aims to fund and develop primary health care services at the grassroots, especially in poor rural areas, and has independent legal personality.
Non-profit 4A-level public fundraising foundation
.

       About Nuoyi®

       Novoeight®, the generic name is Recombinant Human Coagulation Factor VIII for Injection (turoctocog alfa), the English name is Recombinant Human Coagulation Factor VIII for Injection (turoctocog alfa), this product is suitable for adults and children with hemophilia A (congenital coagulation factor) VIII Deficiency) Patients are treated for bleeding as needed and prevented
.
Specifications include 250 IU/piece, 500 IU/piece, 1000 IU/piece, 2000 IU/piece
.

       Nuoyi® is the third-generation B-domain deletion of rFVIII, which guarantees procoagulant activity and a five-step purification process to reduce the risk of pathogen transmission
.
It is safe and effective to prevent and treat bleeding in previously treated patients with severe hemophilia A (PTP), and the incidence of inhibitors in PTP patients is 0
.
The success rate of hemostasis treatment was 95.
4%, and the median annualized bleeding rate of patients receiving preventive treatment was 1.
18 bleedings/patient/year
.

       About Novo Nordisk

       Founded in 1923, Novo Nordisk is a leading global biopharmaceutical company headquartered in Denmark
.
Our goal is to promote change to overcome diabetes, obesity, rare blood diseases, endocrine disorders and other serious chronic diseases
.
To achieve this goal, we lead scientific breakthroughs, expand the company's drug availability, and are committed to preventing and ultimately curing diseases
.
Novo Nordisk has approximately 45,800 employees in 80 countries and regions around the world, and provides products and services to more than 170 countries and regions around the world
.